Section 18

Appendix B: Specifications

157

18 Appendix B: Specifications (con’t)

Performance Over the Duration of Wear

This section presents the performance data in a variety of ways to demonstrate the performance of the system over time during the entire sensor wear period. The sensor is worn on the body for up to 5 days, during which time the system has to be calibrated 4 times. Typically, the system has to be calibrated at 10, 12, 24 and 72 hours after sensor insertion. Data presented in this section demonstrates how the sensor performs as a function of time.

Sensor Stability

Tables 6a-6b show there is little difference in accuracy over the five days of sensor wear according to the Clarke Error Grid Analysis (Table 6a) and the Continuous Glucose-Error Grid Analysis (Table 6b).

Table 6a. Clarke Error Grid Analysis by day of wear

Zone

Day 1

Day 2

Day 3

Day 4

Day 5

 

 

 

 

 

%

%

%

%

%

 

A

82.5

82.4

79.4

84.0

80.9

 

 

 

 

 

 

B

16.4

16.6

18.3

14.2

16.9

 

 

 

 

 

 

C

0.2

0.1

0.0

0.0

0.0

D

0.9

0.9

2.2

1.8

2.1

 

 

 

 

 

 

E

0.0

0.1

0.0

0.0

0.0

 

 

 

 

 

 

Overall Mean Absolute

12.6

12.3

14.1

11.9

13.0

Relative Difference (%)

MARD0

 

 

 

 

 

Table 6b. Continuous Error Grid Analysis by day of wear

Zone

Day 1

Day 2

Day 3

Day 4

Day 5

 

 

 

 

 

%

%

%

%

%

 

Accurate

97.9

97.8

97.1

97.4

97.3

Readings

 

 

 

 

 

Benign

1.0

1.2

0.7

0.8

0.8

Errors

 

 

 

 

 

Erroneous

1.1

1.0

2.2

1.8

1.9

Readings

 

 

 

 

 

Table 6c groups the difference between glucose results from the FreeStyle Navigator system and the YSI into different blocks (within 20%, within 30% and within 40% from the YSI). It shows there is little change in the difference from YSI over time, thus demonstrating sensor stability.

Table 6c. Difference from the YSI at different times after sensor insertion

Time After Insertion

Percent Readings

Percent Readings

Percent Readings

Within 20% of the

Within 30% of the

Within 40% of the

(hours)

YSI*

YSI*

YSI*

 

10-12

86

92

96

12-24

82

93

97

24-72

81

92

97

72-122

82

93

97

*The absolute difference from the YSI reading is measured in mg/dL if the YSI reading is at or below 75 mg/dL.

OVER

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Image 167
Arkon PRT03831-xxx manual Performance Over the Duration of Wear, Sensor Stability
Page 166 Page 168

PRT03831-xxx specifications

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